CLINICAL RESEARCH ASSOCIATE

SUMMARY:
To conduct project activities associated with the monitoring functions of Phase I-IV clinical research studies while continuing to develop his/her knowledge of the drug development process, Good Clinical Practices, and relevant regulations

POSITION INFO:

Duties:

• Complete all types of monitoring visits in accordance with relevant SOPs, regulatory requirements and guidelines, the study protocol, project plan and clinical study monitoring plan to verify the rights and well-being of human subjects are protected;  to ensure the integrity of clinical data and the compliance of the investigator / site. 
• Participate in feasibility activities and reports the outcome to the Clinical Research Physician.
• Provide status updates of pre-study and initiation activities to the Lead CRA / Project Manager.
• Assist in the arranging of study specific training and investigator meetings.
• Attend study specific training and investigator meetings.
• Assist with the submission of documents to the Regulatory Authority and/or Ethics Committees when required.
• Collect, review and track regulatory documents.
• Manage study site activities and provides ongoing site status updates to the Lead CRA / Project Manager.
• Anticipate/identify potential problems and implements corrective actions.
• Ensure proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.
• Complete project administrative activities as appropriate, such as updating in-house site files, and completing visit reports.
• Manage and track payments for investigator sites.
• Participate in quality improvement efforts to increase overall operational efficiency.
• Act in a professional manner at all times

Requirements:

• The incumbent should possess a life sciences degree or nursing qualification
• Minimum 3 years experience to work at a Clinical Research Organization
• Manages investigator site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs)
• Experience in a CRO or Pharma Organization working as a Clinical Research Associate is key

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